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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability is rated 1 because the study followed the standard guideline of reference (OECD 405), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
IUPAC Name:
Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.
Details on test material:
- Name of test material : Sepisol Fast Violet 2B
- Physical state/ appearance: dark violet powder
- Lot/batch No.: 423393
- Storage condition of test material: ambient temperature and in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage GRIMAUD, 49459, FRANCE
- Weight at study initiation: 2.610 kg the day of the test material application
- Housing: Singly housed, in suspended stainless steel cage (60cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe (EVIALIS, 37018 Tours, France)
- Water : ad libitum
- Acclimation period: 5 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/1 2 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the animal serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g
Duration of treatment / exposure:
single exposure followed by contention period of one hour
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 animal.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No removal by washing

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: macroscopic examination and examination with fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean score: 24,48 and 72h after application
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
other: Redness
Basis:
animal #1
Time point:
other: mean score: 24,48 and 72h after application
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean score: 24h, 48 and 72 h after application
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean score: 24h, 48h, 72h after application
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
The test item leads to a non-reversible irritation

Any other information on results incl. tables

Scores

Chemosis

Chemosis score for animal 1

Observation period (after application)

1h

24h

48h

72h

Mean

Day 5 up to 10

Day 11 up to 20

Day 18 up to 20

Day 21

3

4

4

4

4.0

4

3

2

1

Redness

Redness Score

for Animal 1     

                                Observation period (after application)            

 1h

 24h

 48h

 72h

 Mean*

 Day 5 up to 21

 2

 3

 3

 3

 3

 3

Iris

Iris Score

for Animal 1

Observation period (after application)

1h

24h

48h

72h

Mean*

Day 5 up to 21

 

1

1

1

1

1

1

 

Cornea

Cornea Score

for Animal 1     

                                Observation period (after application)            

 1h

 24h

 48h

 72h

 Mean*

 Day 5 up to 21

 0

 2

 2

 2

 2.0

 2

* mean of observed values at 24, 48 and 72h after application

Clinical observations:

 Time Reading     Comments
 Animal #1
 Day 1 (first hour)  Nothing to report
 Day 2 up to day 8  Burned nictitating membrane - Opacity visible to the naked eye -Alopecia
 Day 9 up to Day 14  Mild burning of the nictitating membrane - Corneal opacity visible to the naked eye - Presence of a pannus and alopecia
 Day 15 up to Day 21  Mild burning of the nictitating membrane - Corneal opacity visible to the naked eye - Presence of a pannus and alopecia – Mild cornea edema

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test item is classified as irritant category 1 according to the CLP regulation (EC 1272/2008).
Executive summary:

The aim of this study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance of the effects after

single application of 0.1 g of the pure test material named Sepisol Fast Violet 2B as supplied on eye in one rabbit. The assay was

performed according to the OEDC guideline n° 405.

Ocular reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72 h after application and until the end of the period study (D21). The untreated eye served as control.

The results for the mean score were as follows (mean score 24h, 48h and 72h after application): chemosis: 4.0; redness: 3.0; Iris:1.0 and

Cornea: 2.0. In regards of the results observed and the irreversibility of the lesions at the end of the observation period on D21, the study was not carried out on 2 other rabbits for ethical reasons.

According to the criteria defined in the CLP regulation (EC 1272/2008), the test material is found to be classified as eye damage category 1.